Sensing garment and method for making same

ABSTRACT

A system for monitoring a user includes a garment configured to be placed on a foot of the user, a cover coupled to the garment, and a sensor arrangement between the garment and the cover, wherein the sensor arrangement comprises at least one temperature sensor to measure at least one temperature on the foot of the user. A method for making a system for monitoring a user includes forming a sensor arrangement including at least one sensor lead coupled to a temperature sensor, positioning at least a portion of the sensor arrangement on a garment configured to be placed on a foot of the user, and enclosing at least the portion of the sensor arrangement between the garment and a cover.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims priority to PCT Application No.PCT/CN2018/121244, filed on Dec. 14, 2018, which is hereby incorporatedin its entirety by this reference.

TECHNICAL FIELD

This invention relates generally to the field of foot care and morespecifically to new and useful sensing garments and methods for makingthe same.

BACKGROUND

Diabetes is an increasingly common medical condition in which the bodyhas an impaired ability to produce or respond to the hormone insulin.Diabetes damages blood vessels and nerves, particularly in the feet, andcan lead to severe medical complications that are difficult to treat.For example, one complication of poorly controlled diabetes is footulcers, which may fail to heal because of poor blood circulation indiabetics and because treatment does not always successfully halt thespread of infection. Diabetic foot ulcers are painful and, whenunresolved, can lead to lower limb amputations. As another example,Charcot foot, also known as Charcot arthropathy, is a debilitatingcomplication of diabetes involving fractures and dislocations of bonesand joints that occur with minimal or no known trauma.

Self-care is critical to detecting early signs of ulcers, Charcot foot,and other injuries and allowing timely treatment. However, visualinspection for detecting such conditions has limitations. For example,obese or visually impaired patients may not be able to see their feeteasily. Additionally, due to neuropathy (numbness or loss of feeling asa result of nerve damage) caused by diabetes, a patient may not be ableto feel early development of a foot ulcer and/or fractures. Evenfurther, X-rays are unable to reliably show early stages of fractures.Accordingly, painful and dangerous foot conditions may be detected onlywhen they have progressed to a more severe state, which increases thelikelihood of extreme treatments such as amputation.

Thus, there is a need for new and improved systems and methods formonitoring the feet health of patients.

SUMMARY

Generally, a system for monitoring a user includes a garment configuredto be placed on a foot of the user, a cover coupled to the garment, anda sensor arrangement between the garment and the cover, wherein thesensor arrangement comprises at least one temperature sensor to measureat least one temperature on the foot of the user. In some variations,the garment may include a sole region (e.g., plantar region) and thesensor arrangement may be between the sole region of the garment and thecover. The garment may, for example, include a sock or a shoe insole.

The sensor arrangement may include a plurality of sensor leads, whereeach sensor lead is coupled to a respective temperature sensor. Thesensor leads may be arranged in a bundle, such as a flattened bundle,for traversing the garment (e.g., at least the sole region or plantarregion of the garment). For example, the bundle of sensor leads may beshaped to follow a curved path. In some variations, one or more sensorleads may include a distal portion that diverges from the sensor leadbundle so as to separately position its associated temperature sensor ata desired measurement location on the garment. In some variations, atleast a portion of the bundle may be sealed within a film such as athermoplastic. In some variations, the sensor arrangement may bereceived in a recessed portion in the sole region of the garment, whichcan, for example, reduce the resulting profile of the assembled systemand reduce discomfort and/or injury to a user wearing the garment.

The temperature sensors in the sensor arrangement may be arranged invarious suitable patterns on the garment. In one exemplary variation,the sensor arrangement includes at least one temperature sensor arrangedon the sole region at a location selected from an ossa digit region ofthe garment, between a phalange region and a metatarsal region of thegarment, between the metatarsal region of the garment and a tarsalregion of the garment, and a heel region of the garment.

Furthermore, in some variations, the garment may further include ahousing, where the housing encloses a proximal portion of the sensorarrangement. The housing may further enclose at least one of acontroller, a wireless communication module, a power supply, and amemory.

The cover may be coupled to the sole region around a perimeter of atleast a portion of the sensor arrangement and/or housing, therebyenclosing the sensor arrangement and/or housing between the garment andthe cover. In some variations, the cover may include a textile andconfigured to be heat sealed to the garment.

Generally, a method for making a user monitoring system includes forminga sensor arrangement comprising at least one sensor lead, wherein thesensor lead is coupled to a temperature sensor, positioning at least aportion of the sensor arrangement on a garment configured to be placedon a foot of the user, and enclosing at least the portion of the sensorarrangement between the garment and a cover. In some variations, themethod may further include removing material from the sole region of thegarment to form a recessed portion of the sole region, such that atleast a portion of the sensor arrangement may be positioned in therecessed portion of the sole region. The garment may, for example,include a sock or a shoe insole.

In some variations, the sensor arrangement may be formed into a groupedbundle of sensor leads, each with a respective temperature sensor. Forexample, the sensor arrangement may be formed into a flattened bundle.The bundle may take various shapes. For example, the bundle may beshaped to follow a curved path. In some variations, forming the sensorarrangement may include arranging at least one sensor lead such that itsdistal portion and its respective temperature sensor diverges from thebundle to positioning the temperature sensor at a desired measurementlocation. In some variations, the method may include sealing the sensorarrangement within a film such as a thermoplastic.

In some variations, enclosing at least a portion of the sensorarrangement includes coupling the cover to the garment. For example,coupling the cover to the garment may include coupling the cover to thesole region around a perimeter of at least a portion of the sensorarrangement. Such coupling may be performed with heat sealing, forexample. In some variations, the method may further include enclosing aproximal portion of the sensor arrangement in a housing, and couplingthe housing to the garment.

Systems for monitoring a user may include a garment configured to beplaced adjacent a body part of a user, a cover coupled to the garment,and a sensor arrangement between the garment and the cover, wherein thesensor arrangement comprises at least one sensor to measure at least oneparameter associated with the body part of the user. The at least oneparameter measured by the sensor may be any suitable parameter. Forexample, the at least one parameter measured by the sensor may betemperature, pressure, moisture, strain, user activity, muscle activity,motion, the amount of time the garment is worn, orientation, etc.Furthermore, the garment may, for example, include a sock or a shoeinsole. In some variations, the sensor arrangement may include aplurality of sensor leads, where each sensor lead is coupled to arespective sensor. For example, the garment may include a sole region,and the sensor arrangement may be between the sole region of the garmentand the cover. The cover may be coupled to the sole region around aperimeter of at least a portion of the sensor arrangement. The cover maybe heat sealed to the garment. In some variations, the sensor leads maybe arranged in a flattened bundle traversing the garment. For example,the bundle may be shaped to follow a curved path along the garment. Insome variations, at least a portion of the bundle may be sealed withinflexible film. Sensors may be distributed along the sole region of thegarment in any suitable manner. In some variations, the sensorarrangement may comprise at least one sensor arranged on the sole regionat a location selected from an ossa digit region of the garment, betweena phalange region and a metatarsal region of the garment, between themetatarsal region of the garment and a tarsal region of the garment, anda heel region of the garment.

Methods for making a user monitoring system may include forming a sensorarrangement including at least one sensor lead, where the sensor lead iscoupled to a sensor for measuring at least one parameter associated witha body part of the user, positioning at least a portion of the sensorarrangement on a garment configured to be placed adjacent the body partof the user, and enclosing at least a portion of the sensor arrangementbetween the garment and a cover. The garment may, for example, include asock or a shoe insole. Forming a sensor arrangement may comprisearranging the sensor leads into a flattened bundle. In some variations,methods may include shaping the bundle to follow a curved path. The atleast one parameter measured by the sensor may be any suitableparameter. For example, the at least one parameter measured by thesensor may be temperature, pressure, moisture, strain, user activity,muscle activity, motion, the amount of time the garment is worn,orientation, etc.

Various methods may be used to enclose at least a portion of the sensorarrangement between the garment and the cover. For example, enclosing aportion of the sensor arrangement may comprise coupling the cover to thegarment. In some variations, coupling the cover to the garment maycomprise coupling the cover to the sole region around the perimeter of aportion of the sensor arrangement.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A and 1B are side and bottom views, respectively, of an exemplaryvariation of a system for monitoring a user.

FIG. 1C is a detailed view of a portion of a sensor arrangement and ahousing in an exemplary variation of a system for monitoring a user.

FIG. 1D is an illustrative schematic of sensors and components in ahousing in an exemplary variation of a system for monitoring a user.

FIG. 2 is a bottom view of another exemplary variation of a system formonitoring a user.

FIG. 3 is a side view of another exemplary variation of a system formonitoring a user.

FIG. 4 is a flow chart schematic of an exemplary variation of a methodfor making a user monitoring system.

FIG. 5 is a graphical representation of a portion of an exemplaryvariation of a method for making a user monitoring system.

FIG. 6 is graphical representations of a portion of an exemplaryvariation of a method for making a user monitoring system.

FIGS. 7 and 8 are graphical representations of a portion of an exemplaryvariation of a method for making a user monitoring system.

FIG. 9A is a lower perspective view of an exemplary variation of agarment.

FIG. 9B is an illustrative schematic of components of an exemplaryvariation of a system for monitoring a user.

FIG. 10 is an illustrative schematic of a sensor of an exemplaryvariation of a system for monitoring a user.

FIGS. 11-17 are a lower perspective view, a front view, a rear view, aright side view, a left side view, a top plan view, and a bottom planview, respectively, of an exemplary variation of a garment.

FIGS. 18-24 are a lower perspective view, a front view, a rear view, aright side view, a left side view, a top plan view, and a bottom planview, respectively, of another exemplary variation of a garment.

FIGS. 25-31 are a lower perspective view, a front view, a rear view, aright side view, a left side view, a top plan view, and a bottom planview, respectively, of another exemplary variation of a garment.

FIGS. 32-38 are a lower perspective view, a front view, a rear view, aright side view, a left side view, a top plan view, and a bottom planview, respectively, of another exemplary variation of a garment.

DETAILED DESCRIPTION

Non-limiting examples of various aspects and variations of the inventionare described herein and illustrated in the accompanying drawings.

Generally, described herein are various systems for monitoring a userand methods for making such systems. The system may be a garment (e.g.,sock) worn on the foot of a user and configured to measure one or morephysical characteristics of the user, such as skin temperatures at oneor more locations on a foot of the user. In some variations, a user maywear two garments, including one garment on a left foot of the user, andanother garment on a right foot of the user. Temperature measurementsmay be performed substantially continuously as the garments are worn.

For example, a diabetic user may suffer from diabetic neuropathy andconsequently experience little or no feeling in the user's feet, whichlimits the user's ability to identify development of injuries such assores, ulcers, infection, or poor blood circulation in the user's feet.If left untreated, such conditions may lead to greater medicalcomplications, such as amputation of one or both feet. However, when aregion of a foot becomes infected, the temperature of the affectedregion may generally rise as the body combats the infection.Accordingly, systems described herein, when worn, can providetemperature data that may be analyzed to assess inflammation in diabeticfeet and identify and/or detect development of diabetic footcomplications. In some variations, a sampled temperature differentialbetween corresponding locations on left and right feet of the user canbe compared to a baseline temperature differential between the samecorresponding locations. A threshold change between the baseline andsampled temperature differential (e.g., a change of about 4° F. or more)can indicate, for example, an early sign of diabetic foot ulcers.Exemplary methods for assessing foot inflammation based on foottemperature measurements from the system are described in U.S. PatentApp. Pub. No. 2017/0188841, which is hereby incorporated in its entiretyby this reference.

Systems described herein can provide substantially continuoustemperature measurements at various locations of the user's feet, whichenable a more effective prediction and/or detection of diabetic footconditions compared to conventional methods of assessment. Conventionalmethods for monitoring diabetic foot conditions include using a handheldfoot thermometer to measure temperature at selected locations of thefoot. Such tools are designed to measure temperatures once a day or atlong intervals. However, these tools fail to provide a comprehensivetemporal and spatial understanding of temperature pattern data. Incontrast, continuous monitoring allows the assessment of temperatureover longer periods and with more temporal resolution, such thatmicropatterns (e.g., over the course of an hour or through the day) canbe taken into consideration when assessing for development of footconditions in the user. For example, a once-a-day measurement maycapture a temporarily normal-looking temperature characteristic of auser's foot, but fail to capture subsequent signs of inflammation laterin the day as the result of the day's activities. In contrast,continuous monitoring can facilitate analysis of temperature patterns(both spatial and temporal) specific to a user, for more accurateassessments. Furthermore, the systems herein may incorporate activitydata (e.g., from an accelerometer, pedometer, etc.) such that analysiscan take into consideration varying levels of user activity over time(and assess how activity affects temperature patterns). Accordingly,continuous monitoring has a greater potential to report consistent andclinically relevant temperature increases. Thus, systems such as thosedescribed herein, which provide continuous temperature monitoring, havethe potential to further improve home care and early detection ofdiabetic foot conditions. Variations of such systems, and methods formaking such systems, are described in further detail below.

System for Monitoring a User

In some variations, as shown in FIGS. 1A and 1B, a system 100 formonitoring a user can include a garment 110 configured to be placed on afoot of the user where the garment may include a sole region 112, acover 130 coupled to the garment 110, and a sensor arrangement 120between the garment (e.g., the sole region 112 of the garment) and thecover 130, where the sensor arrangement includes at least onetemperature sensor to measure at least one temperature on the foot ofthe user. For example, in some variations, as shown in FIG. 1B, thesensor arrangement may include a plurality of temperature sensors 124arranged in different regions of the garment so as to measuretemperature at various locations on sole of the foot of the user.

Garment

The garment of the system 100 provides a substrate or platform for thesensor arrangement, and positions the sensors relative to desiredmeasurement locations of the user when the garment is worn. In somevariations, the garment includes a sock configured to be placed or wornon a foot of the user. However, the garment may alternatively be anysuitable component to be positioned on the foot such as a shoe, aslipper, an insole, etc. For example, in some variations, a garment maybe a shoe or shoe component configured to house a sensor arrangement.For example, the shoe may include an insole configured to receive one ormore sensor arrangements. The insole may include one or more sensorarrangements coupled to the insole by a cover. The garment may beconfigured specifically for a left foot (e.g., include a toe boxaccommodating contours of a left foot), for a right foot (e.g., includea toe box accommodating contours of a right foot), or may be universallyor suitable for both feet. The garment may include one or more labelsthat are sewn, woven, or otherwise incorporated into or coupled to thegarment. Examples of labels include an indication of left or right footcompatibility, size (e.g., small, medium, large, or numeric size), orother identifying info.

Furthermore although the methods and systems are primarily describedherein with respect to a foot garment, it should be understood that inother variations, the garment may be any suitable garment (e.g. pants,short pants, tights, leggings, leg warmer, shirt, arm warmer, glove,mitten, scarf, hat, headband, etc.) configured to be placed adjacent toone or more suitable body parts of the user for monitoring.

As shown in FIG. 1A, in some variations, the garment 110 may include asole region 112 (e.g. plantar region) configured to receive a foot of auser, and an ankle region 114 extending from the sole region 112. Atleast the sole region 112 may include a flexible material such as atextile (e.g., polyester, cotton, etc.) that is configured to conform tothe foot of the user, such that when the garment is worn, temperaturesensors coupled to the sole region of the garment may be positionedclosely adjacent to skin of the user for providing accurate skintemperature measurements. The ankle region 114 may also include aflexible material such as textile that is configured to conform to thelower leg of the user. Additionally or alternatively, the ankle region114 (and/or other regions of the garment such as medial or lateralaspects of the foot portion of the garment, a top or dorsal region ofthe foot portion of garment, etc.) may include one or more temperaturesensors for providing skin temperature measurements (and/or other kindsof sensors). For example, one or more sensors may be arranged on thegarment so as to measure skin temperature of the ankle and/or leg (e.g.,lower leg).

In some variations, the sole region 112 and/or the ankle region 114 mayinclude one or more recessed portions for receiving at least a portionof the sensor arrangement. The recessed portions may be on an internalsurface of the garment or on an external surface of the garment. Thedepth of the recessed portions may be similar to (e.g., approximatelyequal to) or greater than the thickness of the sensor arrangement, suchthat when the sensor arrangement is received in the recessed portions,the sensor arrangement does not significantly extend beyond the profileof the garment material. Accordingly, one or more recessed portions onthe sole region of the garment may advantageously help reduce localizedpressure points (thereby reducing development or exacerbation of footinjuries caused by the user stepping on the sensor arrangement) and/orreduce the likelihood of damage to the sensor arrangement.

The recessed portions may be formed in any suitable manner. For example,the garment may generally be made of a plush or thickened material(e.g., terry knit), which may increase user comfort, the garment mayinclude one or more recessed portions formed by reducing some of thethickness of the material across a selected area corresponding to theeventual location of the sensor arrangement on the garment.Alternatively, the garment may be woven or knit to have varyingthickness, including a thinner portion that forms the one or morerecessed portions. In some variations, the one or more recessed portionsmay be patterned to have a shape similar to that of the sensorarrangement. For example, as shown in FIG. 1B, a recessed portion(underlying the cover 130) may generally resemble the outline or path(s)of the sensor leads 122 of the sensor arrangement. Similarly, as shownin FIG. 1A, a recessed portion (underlying the cover 130) may have arectilinear path following the path(s) of the sensor leads 122 extendingfrom the sole region 112 of the garment to the ankle region 114 of thegarment. In other words, the outline of a recessed portion 116 maysubstantially correspond to the outline of the sensor arrangement. Insome variations, the recessed portion 116 may extend an additionalmargin (e.g., at least about 0.5 cm) beyond the outline of the sensorarrangement. This additional margin may, for example, account fortolerance in the size and shape of the sensor arrangement received inthe recessed portion 116, and/or enable some space for movement (e.g.,flexing) of the sensor leads when the garment is stretched,repositioned, etc.

However, alternatively, the one or more recessed portions may have anysuitable shape (e.g., a suitable shape extending beyond the perimeter ofthe sensor arrangement). For example, with reference to the variationshown in FIG. 2, a recessed portion receiving the sensor arrangement mayhave a generally rectangular shape, similar to the cover 230.

Housing

In some variations, the garment may further include at least one housing140. As shown in FIG. 1C, the housing 140 may include at least onecavity 142 for receiving a proximal end of the sensor arrangement 120 asfurther described below, and/or housing other various components. Thehousing 140 may, for example, be arranged on an ankle region of thegarment. In some variations, the housing 140 may be located on a lateralside of the garment. A lateral positioning of the housing may make thehousing comfortable for the use (e.g., because a housing positioned on alateral side of a garment is unlikely to interfere with walking andother activities). However, in other variations, the housing may belocated on any suitable portion of the garment (e.g., medial side,anterior side, posterior side, distal side, etc.). In some variations,the housing 140 may be secured to the garment by being enclosed betweenthe garment and a cover (similar to the sensor arrangement as describedbelow). Additionally or alternatively, the housing may be coupled to thegarment with an adhesive or mechanical fasteners (e.g., rivets, snaps,etc.), by being inserted into a pocket or other receptacle on thegarment, sewn to the garment, or in any suitable manner.

The housing may be substantially sealed (e.g., hermetically sealed orwaterproofed) to protect the contents of the housing from environmentalconditions (e.g., when the garment is washed or worn, when the user issweating, etc.). For example, the cavity 142 may be filled with and/orotherwise sealed with a substance adhering to the housing 140, such asultraviolet glue, silicone, other epoxy or polymer, etc. This substancecan help fix the proximal end of the sensor arrangement 120 and/or othercomponents within the housing 140. As another example, the housing 140may include one or more components that may be coupled together (e.g.,with a suitable mechanical interfit, fasteners, weld, etc.). The jointbetween coupled housing components may be sealed by epoxy or othersuitable sealant. In some variations, the one or more components of thehousing may be formed at least in part through injection molding.

As shown in the schematic of FIG. 1D, the housing 140 may house variouscomponents for operating the system. For example, the housing 140 mayinclude at least one processor 152 (e.g., CPU), at least one memorydevice 154 (which can include one or more computer-readable storagemediums), at least one communication module 156, and at least one powersource 158. In some variations, the housing may further include one ormore additional activity or other sensors (e.g., an accelerometer, agyroscope, or an inertial measurement unit). One or more of thesecomponents may be arranged on one or more electronic circuit boards(e.g., PCBA), which in turn be mounted to the housing.

The processor 152 and memory device 154 may cooperate to provide acontroller for operating the system. For example, the processor 152 mayreceive sensor data from one or more sensors 124 (e.g., firsttemperature sensor 124 a, second temperature sensor 124 b, thirdtemperature sensor 124 c, etc.), and the sensor data may be stored inone or more memory devices 154. In some variations, the processor 152and memory 154 may be implemented on a single chip, while in othervariations they can be implemented on separate chips.

The controller can operate in an inactive state and in an active state.The controller may, for example, toggle between the inactive state andthe active state based on user input (e.g., pressing of a button) and/orsensor data (e.g., from activity sensors, processing of temperaturedata, etc.) suggesting placement of the garment on a user. In theinactive state, the controller may be in a “sleep” mode (e.g., toconserve energy in the power source 158). In the active state, thecontroller may be in an “awake” mode in which sensor data is received,processed, and/or stored in the memory device 154 for use in monitoringfor inflammation. For example, in its active state, the controller mayscan at least some of the temperature sensors to receive and storetemperature measurement data (e.g., periodically, such as every second,every 10 seconds, every 30 seconds, every minute, every hour, or othersuitable interval). Generally, the controller may operate in theinactive state when there is an indication that the garment is not beingworn by the user, and may operate in the active state when there is anindication that the garment is being worn by the user. In somevariations, the controller may be similar to the controller described inU.S. Patent Pub. No. 20170188841, incorporated by reference above.

The communication module 156 may be configured to communicate sensordata and/or other information to an external computing device 170. Theexternal computing device 170 may be, for example, a mobile computingdevice (e.g., mobile telephone, tablet, smart watch), laptop, desktop,or other suitable computing device. The external computing device 170may be executing a native application for presenting sensor data (and/orthe results of analysis thereof) through a user interface to a user.Additionally or alternatively, the communication module 156 may beconfigured to communicate to one or more networked devices, such as ahub paired with the system, a server, a cloud network, etc.

The communication module 156 may communicated via a wired connection(e.g., including a physical connection such as a cable with a suitableconnection interface such as USB, mini-USB, etc.) or a wireless network(e.g., through NFC, Bluetooth, WiFi, RFID, or any type of digitalnetwork that is not connected by cables). For example, devices maydirectly communicate with each other in pairwise connection (1:1relationship), or in a hub-spoke or broadcasting connection (“one tomany” or 1:m relationship). As another example, the devices maycommunicate with each other through mesh networking connections (e.g.,“many to many”, or m:m relationships), such as through Bluetooth meshnetworking. Wireless communication may use any of a plurality ofcommunication standards, protocols, and technologies, including but notlimited to, Global System for Mobile Communications (GSM), Enhanced DataGSM Environment (EDGE), high-speed downlink packet access (HSDPA),high-speed uplink packet access (HSUPA), Evolution, Data-Only (EV-DO),HSPA, HSPA+, Dual-Cell HSPA (DC-HSPDA), long term evolution (LTE), nearfield communication (NFC), wideband code division multiple access(W-CDMA), code division multiple access (CDMA), time division multipleaccess (TDMA), Bluetooth, Wireless Fidelity (WiFi) (e.g., IEEE 802.11a,IEEE 802.11b, IEEE 802.11g, IEEE 802.11n, and the like), or any othersuitable communication protocol. Some wireless network deployments maycombine networks from multiple cellular networks or use a mix ofcellular, Wi-Fi, and satellite communication.

Additionally, the housing may include one or more power sources 158,which may function to provide electrical power to the processor,communication module, sensors, and/or any other electrical components.For example, the power source 158 may include one or more batteries. Insome variations, the power source 158 may be rechargeable such asthrough wireless charging methods (e.g., inductive charging, RFcoupling, etc.) or by harnessing kinetic energy such as that generatedthrough motion (e.g., when the user walks while wearing the garment).

Sensor Arrangement

As shown in FIGS. 1A and 1B, a sensor arrangement 120 may be positionedon the garment 110, such as an internal surface of the garment. Thesensor arrangement 120 functions to gather measurements, including skintemperature measurements of the user, when the garment 110 is placed onthe foot of the user. Although the description below references sensorarrangements including temperatures sensors, sensor arrangements mayinclude any suitable type of sensor, such as a pressure sensor, amoisture sensor, a strain sensor, a weight sensor, a movement/activitysensor, a muscle activity (e.g., EMG) sensor, an orientation sensor, asensor that tracks the amount of time a garment is worn (e.g., todetermine compliance with a treatment plan), etc. Further, sensorarrangements may comprise more than one type of sensor (e.g., a sensorarrangement may comprise a temperature sensor and a strain sensor).

The sensor arrangement 120 may include one or more sensor leads 122,where each sensor lead is coupled to a respective temperature sensor124. The temperature sensor 124 may be located at the distal end of itsrespective sensor lead. For example, the sensor arrangement 120 mayinclude one or more thermistors, thermocouples, or other suitabletemperature sensors. In some variations, some or all of the sensor leads122 may be coated in a material such as fabric (e.g., polyester sleeve)which may, for example, increase overall strength of the sensor lead andhelp guard against failure due to applied stresses.

Generally, the sensor leads 122 may be grouped together (e.g., in abundle), which may have multiple advantages. For example, compared to asingle lead, the increased collective bulk (e.g., increasedcross-sectional area) of the grouped sensor leads 122 may be lesssusceptible to stresses imparted on the sensor arrangement (e.g., whenthe user's weight is placed on the sensor arrangement, when the garmentis stretched, etc.). Thus, the grouping or bundling of sensor leads 122may make the sensor arrangement 120 more robust and less prone tofailure. Additionally, the grouping of sensor leads 122 allows thesensor leads to be collectively manipulated with ease during assembly,thereby making assembly of the system (e.g., positioning of the sensorarrangement on the garment) easier and faster than assembly would bewith individual sensor leads. In some variations, the bundle may be aflattened bundle having a low profile. For example, the group of sensorleads 122 may be arranged side-by-side in a single layer in a flattenedbundle. Such a flattened bundle may, for example, may be morecomfortable underfoot for the wearer of the garment.

In some variations, the sensor arrangement 120 may be positioned on thegarment generally within the one or more recessed portions of thegarment described above. In an exemplary variation shown in FIG. 1A, aproximal end of the sensor arrangement 120 may be received in thehousing, where proximal ends of sensor leads 122 may be coupled (e.g.,soldered) to respective signal-receiving pins on the processor or othercomponents. In some variations, the sensor arrangement 120 may extendfrom the housing 140 along the ankle region 114 of the garment 110, wraparound the lateral side of the garment toward the sole region 112 of thegarment as shown in FIG. 1B. In some variations, the sensor arrangementmay wrap around a heel region of the garment as it extends toward thesole region. The sensor leads 122 may traverse the sole region 112 ofthe garment in any suitable path to locate the temperature sensors (atthe distal ends of the sensor leads 122) at the desired measurementlocations. As described in further detail below, in some variations, thesensor arrangement may be secured to the garment via the cover coupledto the garment. However, the sensor arrangement may additionally oralternatively be secured to the garment with epoxy or other adhesive,sutures, connectors or fasteners, etc.

In some variations, the sensor arrangement may form a curved path as itextends from the housing to the sole region of the garment. In anexemplary variation of a garment 910 shown in FIGS. 9A and 9B, aproximal end of the sensor arrangement 920 is received by the housing940, and the sensor arrangement 920 extends from the housing 940 alongthe ankle region 914 toward the sole region 912 of the garment. In thisvariation, the sensor leads are grouped together in a bundle as theyextend along the ankle region of the garment, and the respective sensorleads branch off to various locations along the sole region 912 of thegarment (e.g., to desired sensing locations). As depicted in FIG. 9A,the sensor arrangement 920 traverses a heel region 916 of the garment ina curved configuration. The sensor arrangement 920 wraps around the heelregion 916 of the garment in a substantially “S-shaped” configuration.The curved configuration of the sensor arrangement 920 may provide thebenefit of reducing the strain on the sensor arrangement. For example,the curved configuration of the sensor arrangement provides excesslength of sensor such that as the garment is stretched (e.g., as theuser is putting the garment on or taking it off), the curved portion isstraightened rather than the sensor arrangement being placed understrain. Thus, the curved portion of the sensor arrangement introduces aform of slack such that the garment can be stretched without harming thesensor arrangement.

FIG. 9B shows a schematic depiction of an exemplary sensor arrangement920 with a curved configuration, similar to that shown in FIG. 9A. Inthis variation, the sensor arrangement 920 includes a plurality ofsensor leads, where the proximal end of each sensor lead is received bya housing 940. Each sensor lead in the arrangement includes a sensor(e.g., a temperature sensor) at a distal end of the lead. The sensorarrangement of FIG. 9B includes numerous curved portions. The curvedportions may curved at any suitable angle to traverse to desired sensorlocations. In FIG. 9B, the curved portions are configured so as tocircumvent high flex areas of the heel region 916 to avoid excessivestrain on the sensor leads. In the variation depicted in FIG. 9B, thesensor arrangement includes curves with angles A and B configured tocurve around one or more high flex areas of the heel region 916 of thegarment 910. Angle A may, for example, be between about 65 degrees andabout 90 degrees, between about 70 degrees and about 80 degrees, orabout 78 degrees. Angle B may, for example, be between about 40 degreesand about 60 degrees, between about 45 degrees and about 55 degrees, orabout 51 degrees.

Although the sensor arrangements 920 in FIGS. 9A and 9B form asubstantially S-shaped path, any curved configuration may provide asimilar benefit of reducing the impacts of strain on the sensorarrangement, and circumventing areas of a garment that may experiencehigh levels of flexion and/or strain. Further, the sensor arrangementmay have a curved configuration along any suitable portion of thegarment. Although FIG. 9A shows the curved portion of the sensorarrangement 920 as extending along the heel region 916 of the garment910, the curved portion may be at any suitable location along thegarment. For example, in some variations, the sensor arrangement maycomprise a curvature over its entire path along the ankle region of thegarment.

In some variations, sensor leads may be housed in a protective material.For example, in the variation shown in FIG. 9B, the sensor leads may bebundled and contained within protective, flexible film 950 (e.g., aplastic, such as a polyurethane film) (e.g., sealed between two layersof film 950). A protective film 950 may provide the benefit ofprotecting the sensors from damage and/or outside moisture, and may bewaterproof or water-resistant. The sensor arrangement 920 of FIG. 9B mayalso be contained within a cover 930. The cover may couple the sensorleads to the garment 910, and direct the sensor leads along a path fromthe ankle region 914, to the sole region 912 of the garment 910. Theshape of the film 950 and/or cover 930 may closely approximate thecurved shape of the sensor arrangement 920. In some variations, thecover 930 may be a recessed portion or a cover portion of a garment,such as that of a sock or a shoe, for example.

Turning back to FIGS. 1A-1D, generally, the sensor leads 122 may bearranged to distribute the temperature sensors 124 among a variety ofdiscrete target regions of the garment, so as to measure skintemperature at different locations of interest when the garment isplaced on a user's foot. In some variations, measurement locations ofinterest may include locations typically experiencing high pressure whenthe user is active (e.g., walking or standing). For example, the sensorarrangement may be constructed so as to arrange the one or moretemperature sensors on the sole region of the garment. In one exemplaryvariation, the temperature sensors 124 may include six temperaturesensors. One temperature sensor 124 a may be positioned in a firstregion of the garment configured to contact an Ossa digit of the foot,or toe. For example, the temperature sensor 124 a may be configured tocontact skin overlying the first Ossa digit (“big toe”) of the foot.Three temperature sensors 124 b, 124 c, and 124 d may be positioned in asecond region of the garment configured to contact skin overlying theboundary of the phalanges and the metatarsals of the foot. For example,the temperature sensors 124 b, 124 c, and 14 d may be configured tocontact skin proximate the first (most medial) metatarsal, the thirdmetatarsal, and the fifth metatarsal, respectively. Additionally,another temperature sensor 124 e may be positioned in a third region ofthe garment configured to contact skin overlying the boundary of themetatarsals and the tarsals of the foot. Furthermore, anothertemperature sensor 124 f may be positioned in a fourth region of thegarment configured to contact skin overlying the heel of the foot. Theconfiguration of temperature sensors may be biased for a left foot ininstances in which the garment is configured to be placed on a leftfoot, while the configuration of temperature sensors may be biased for aright foot in instances in which the garment is configured to be placedon a right foot.

In other variations, the sensor arrangement may be constructed so as toadditionally or alternatively arrange one or more temperature sensors onother regions of the garment (e.g., medial or lateral sides of a footregion of the garment, dorsal portion of a foot region of the garment,ankle region of the ankle, etc.).

In locating the temperature sensors to their respective measurementlocations, the sensor leads 122 may traverse the sole region in a curvedpath which may, for example, provide additional strain relief to thesensor arrangement (e.g., the curved pattern can better withstandstretching, etc.). For example, the curved path may be generally“S”-shaped, serpentine, or other suitable non-linear path. In somevariations, as shown in FIG. 1B, the distal end of one or more sensorleads 122 (and their temperature sensors) may diverge or branch from thesensor lead bundle such that the temperature sensor attached to adiverging sensor lead is independently positioned at a desiredmeasurement location. Additionally or alternatively, at least a portionof the sensor lead bundle may traverse the sole region 112 betweendifferent measurement locations in series, such that at least somesensor leads are not substantially diverging or branching from the mainbundle. For example, FIG. 2 illustrates a variation in which the bundleof sensor leads for temperature sensors 224 a-224 e navigates to fivemeasurement locations in series, with individual sensor leads simplyterminating at their respective sensors' measurement locations. In thisexample, some of the sensor leads may be shorter than others. In theexample of FIG. 2, the sensor lead for temperature sensor 224 f divergesfrom the main bundle of sensor leads, while the other sensor leads donot substantially diverge. It should be understood, however, that thereare many suitable configurations in which the sensor leads traverse thesole region of the garment to position the temperature sensors at thedesired measurement locations. For example, the distal ends of none,some, or all sensor leads (in any combination) may diverge from a mainsensor lead bundle to position respective temperature sensors.Furthermore, none, some, or all sensor leads (in any combination) maynavigate to measurement locations in series (in any permutation ororder), in a non-diverging manner, to position respective temperaturesensors.

In some variations, a sensor lead may have a coiled or serpentineconfiguration at a distal end proximate to the sensor. For example, FIG.10 is a schematic representation of a distal end of a sensor lead 1022and a sensor 1024 coupled to the distal end of the sensor lead. In thisvariation, the sensor lead 1022 includes a serpentine configuration 1023near the distal end. As described above, arranging the sensor leads in acurved configuration may provide strain relief to the sensorarrangement, and reduce the risk that a sensor lead will become damaged.In some variations, a serpentine configuration at a distal end of asensor lead may be more tightly curved than the curvature of the sensorleads elsewhere. Sensor leads may be placed under higher levels ofstrain at their distal ends near sensors due to pressure and movement ofthe sensor. Thus, the distal end of the sensor leads may be moresusceptible to breakage or other forms of damage than other portions ofthe sensor lead. Therefore, a curved portion such as a coiled orserpentine configuration at the distal end of the sensor lead near thesensor may be beneficial.

In some variations, the relative positions and orientations of some orall the sensor leads (and accordingly, the relative positions of therespective sensors) may be fixed with additional components. Forexample, once arranged in a configuration such as that described above,at least some of the sensor leads may be coupled to each other withepoxy or fasteners (e.g., ties, clips, etc.). Additionally oralternatively, at least some of the sensor leads may be collectivelysealed together, such as sealed between multiple (e.g., upper and lower)layers of film or vacuum-sealed in a bag. Suitable film may be, forexample, layers of polyurethane or other polymer. Accordingly, suchsealing of the sensor arrangement may set the arrangement of sensorleads 122 (including the grouping or bundling of sensor leads, and therelative positions of the sensors) for us during assembly.

Cover

Generally, the system may further include at least one cover 130 coupledto the garment 110 such that the sensor arrangement and/or housing islocated between the garment and cover. In some variations, theattachment of the cover 130 to the garment 110 may thereby secure thesensor arrangement and/or housing to the garment. The cover may becoupled to an internal surface of the garment, over a sensor arrangementand/or housing positioned on the inner surface of the garment.Alternatively, the cover may be coupled to an external surface of thegarment, over a sensor arrangement and/or housing positioned on theouter surface of the garment.

In some variations, the cover may include a single piece. Alternatively,the cover may include multiple pieces that collectively enclose thesensor arrangement over the garment. For example, the cover may includean ankle cover portion sized and shaped to secure an ankle portion ofthe sensor arrangement 120 and/or the housing to the ankle region 114 ofthe garment, and a sole cover portion sized and shaped to secure a soleportion of the sensor arrangement 120 to the sole region 112. In thisexample, the ankle cover portion and sole cover portion may be coupledto each other and subsequently collectively coupled to the garment, ormay individually and separately be coupled to the garment only. Itshould be understood that the cover may include any suitable number ofcover segments that collectively cover the sensor arrangement and/orhousing.

For example, as shown in FIGS. 1A and 1B, the cover 130 may be attachedto the garment 110 around the perimeter of at least a portion of thesensor arrangement 120. In some variations, the shape of the cover mayclosely resemble the shape of the sensor arrangement 120 (e.g., slightlylarger than the outline of the sensor arrangement, such as by a marginof at least about 0.5 cm).

Alternatively, in some variations, the cover may have any suitable shapeand size larger than the outline of the sensor arrangement 120. Forexample, as shown in FIG. 2, a system 200 may include a cover 230 may begenerally rectangular and larger than the overall area of the sensorarrangement on the sole region of the garment. In other variations, thecover 230 may be oval, circular, or other suitable shape. As anotherexample, as shown in FIG. 3, a system 300 may include a cover 330 thatprovides a second layer to a substantial portion of the garment 310(e.g., the sole region and at least part of the ankle region) such thatthe sensor arrangement 320 is layered between (“sandwiched” orlaminated) between the garment and cover.

The cover may include any of various suitable materials. For example,the cover may include a textile (e.g., polyester, cotton, etc.) that iscut to a desired shape. In some variations, such a textile cover may belined with a material suitable for heat sealing the cover to thegarment, such as a thermoplastic material (e.g., thermoplasticpolyurethane). Additionally or alternatively, the textile cover may becoupled to the garment with epoxy or other adhesive, sutures, and/orfasteners (e.g., rivets). In other variations, the cover may include anepoxy or other adhesive (e.g., silicone glue), or sewn threads (e.g.,embroidery) that directly secures the sensor arrangement to the garment.

Additional aspects of manufacturing the user monitoring system describedherein are described in further detail below.

Method for Making a User Monitoring System

In some variations, as shown in FIG. 4, a method 400 for making a usermonitoring system includes forming a sensor arrangement comprising atleast one sensor lead (420), positioning at least a portion of thesensor arrangement on a region (e.g., sole region) of a garment (430),and enclosing at least the portion of the sensor arrangement between theregion of the garment and a cover (440). In some variations, the method400 may further include preparing a garment (410) to receive the sensorarrangement, as further described below, though in some variations thegarment may be pre-prepared and already configured for receiving asensor arrangement. Generally, the method 400 may be performed to makeat least part of the systems described above for monitoring a user.Although the method is primarily described with reference to making afoot-borne garment such as a sock, it should be understood thatvariations of the method 400 may be used to make similar monitoringsystems with other garments or for other body parts (e.g., slippers,insoles, gloves, pants, shirts, etc.).

Preparing the Garment

FIG. 5 generally illustrates aspects of preparing the garment (410). Asshown in FIG. 5, a garment may be prepared by forming one or morerecessed portions 116 of the garment 110, where the one or more recessedportions may be configured to receive the sensor arrangement and reducethe overall profile of the garment that otherwise would be increased asa result of the sensor arrangement. For example, the garment may includea plush material (e.g., terry knit) that can be thinned or cut shorter(e.g., with a cutting blade, scissors, a razor, and the like) inselected regions where a recessed portion is desired. In somevariations, the one or more recessed portions 116 of the garment may bearranged on an internal (skin-contacting) surface of the garment. Forexample, the garment may be turned inside out to allow access to theinternal surface of the garment, and the internal surface of the garmentmay be trimmed to form the recessed portions 116. The garment may remaininside out for positioning and coupling the sensor arrangement and coverto the internal surface of the garment as described below. In othervariations, the one or more recessed portions 116 may be arranged on anexternal surface of the garment.

As shown in the variation of FIG. 5, the recessed portions 116 maygenerally resemble the footprint area or shape of the sensor arrangement(e.g., a branching pattern on the sole region of the garment 110, withdiverging branches or lobes corresponding to sensor locations). However,the recessed portions 116 may have any suitable size and shape forreceiving at least part of the sensor arrangement. Additional patternsfor recessed portion are described above, for example.

Forming the Sensor Arrangement

FIG. 6 generally illustrates aspects of forming the sensor arrangement(420). For example, the sensor arrangement may be formed at least inpart by arranging individual sensor leads into a bundle (610) or othergrouping. The bundle may, for example, be a flattened bundle with a lowprofile (e.g., sensor leads arranged side-by-side in a single layer).The bundle may be shaped with any suitable number of sensor leads with adistal end that diverges from the bundle for separately positioning atemperature sensor coupled to the distal end of the sensor lead. Variousexamples of sensor lead configurations are described in further detailabove.

There are several suitable methods for arranging the sensor leads into abundle 612. In one exemplary variation, the sensor leads may be arranged(e.g., manually or automatically with tooling, etc.) with the assistanceof a fixture having one or more open channels (e.g., groove) that isshaped to resemble the desired sensor lead layout. Sensor leads may beplaced into the open channels, which gathers and shapes the sensor leadsinto the desired shape. Similarly, in another exemplary variation, thefixture may include one or more closed channels (e.g., lumens) shaped toresemble the desired sensor lead layout. In this variation, sensor leadsmay be fed longitudinally into the closed channels, which similarlygathers and shapes the sensor leads into the desired shape. In yetanother exemplary variation, the sensor leads may be manually arrangedin a free-form manner on a surface. The surface may include, forexample, an outline or reference markers guiding placement of the sensorleads.

In some variations, after the sensor leads are arranged into a bundle612 or other suitable pattern, the arrangement may be sealed orotherwise set, in order to fix the relative positions of the sensorleads. For example, as shown in FIG. 6, at least a portion of thearranged sensor leads may be laminated between layers of thermoplasticfilm 622 and 624 (e.g., thermoplastic polyurethane, or otherthermoplastic), such as with heat sealing. Other examples of fixing thesensor arrangement include sealing in a bag (e.g., vacuum sealing), andcoupling sensor leads together with adhesive, fasteners, threads, etc.

The proximal ends of the sensor leads in the sensor arrangement mayremain exposed (unsealed) so as to allow electrical connection forsensor data communication. As shown in FIG. 6 for example, the proximalends of the sensor leads may be connected (e.g., soldered) to pins ofone or more processors in a housing 634 or other suitable connector. Theconnection between the sensor leads and the processors may be protectedby applying a substance (e.g., UV glue, silicone glue, putty, etc.) overthe electrical connection, and/or otherwise the connection region withthe housing.

Forming a Cover

In some variations, the cover may include a flexible material that mayformed into a suitable shape for covering the sensor arrangement andcoupling to the garment. The cover may include a single or multipleportions. In an exemplary variation, the cover may include a materialconducive to heat sealing, such as a textile (e.g., polyester or othersuitable fabric) lined with a thermoplastic (e.g., thermoplasticpolyurethane). However, in other variations the cover may include atextile otherwise coupleable to the garment via epoxy, fasteners, etc.Generally, a textile cover may be formed by cutting the cover shape fromthe textile (e.g., with scissors, laser cutting, etc.). Accurate cuttingof the cover shape may be facilitated with a template, jig, and/or othersuitable tooling. Suitable exemplary cover shapes are described infurther detail above.

Assembling the Garment and Sensor Arrangement

FIGS. 7 and 8 generally illustrate aspects of one variation ofassembling the garment and the sensor arrangement. Specifically, FIG. 7illustrates an exemplary process of enclosing the sensor arrangementbetween a sole region of the garment and a cover lined with athermoplastic or similar material suitable for heat sealing. At leastthe sole region of the garment 716, a sole portion of the sensorarrangement 714, and a sole portion of the cover 712 may be stacked andaligned such that the sole portion of the sensor arrangement iscontained between the garment and cover.

Various tooling apparatus may be added to the stack of systemcomponents. A forming block 710 may be placed over the cover 712, wherethe forming block 710 has a contact surface defining where the heatsealing will be applied. The forming block 710 may include a raisedouter edge resembling the perimeter of the sensor arrangement (withadditional sufficient margin, such as about 0.5 cm or greater). Theforming block 710 may include a recessed portion corresponding to theshape of the sensor arrangement (or a recessed area at least as large asthe sensor arrangement), such that the forming block protects the sensorarrangement from damage during subsequent compression of the assembledstack. Furthermore, in some variations, a heat-conductive model insert718 may be inserted into the garment such that is provides a backingbehind the sensor arrangement. The model insert 718 may, for example, bemade of steel.

In order to heat seal the cover to the garment, it may be beneficial toflatten the garment, for example, to prepare for stacking of the systemcomponents used in heat sealing as described above. The garment may beflattened in any suitable manner. For example, the garment may beflattened from top to bottom, such that the sole portion of the garmentis stacked on top of the ankle portion. In another variation, thegarment may be flattened from side to side, such that the left side ofthe garment is stacked on top of the right side, or vice versa.Flattening the garment from side to side in preparation for heat sealingmay provide the benefit of avoiding the creation of a fold or crease inthe ankle region of the garment.

Heat and compression may be applied to the assembled stack of systemcomponents and tooling apparatus. For example, the model insert 718 maybe heated (e.g., via an accessible portion of the model insert).Simultaneously, the stack may be compressed (e.g., with a clamp, vise,or similar device), such that heat from the model insert 718 inducessealing between the thermoplastic lining of the cover and the garment.As an addition or alternative to heat and compression, the cover may becoupled to the garment in other suitable ways such as by sewing or withfasteners. Following this process, the sensor arrangement 714 isenclosed between the sole region of the garment 716 and the cover 712.

FIG. 8 illustrates an exemplary process of enclosing the sensorarrangement and/or housing between an ankle region and the cover.Generally, this process may be similar to the process described abovewith reference to FIG. 7, except the assembled stack of systemcomponents includes an ankle region of the garment 816, an ankle portionof the sensor arrangement 814 and/or housing 815, and an ankle region ofthe cover 812 that are aligned such that the ankle portion of the sensorarrangement is contained between the garment and the cover. The formingblock 810 may include a raised outer edge resembling the perimeter ofthe sensor arrangement and/or housing (with additional sufficientmargin), and a recessed portion to protect the sensor arrangement duringcompression. Similar to that described above, heat and compression maybe applied to the assembled stack. As an addition or alternative to heatand compression, the cover may be coupled to the garment in othersuitable ways such as by sewing or with fasteners. Following thisprocess, the sensor arrangement 814 is enclosed between the ankle regionof the garment 816 and the cover 812.

In some variations, the model insert may be omitted from the stack. Invariations, any other rigid backing, such as a flat workspace surface,may support the compression and/or provide heating. Furthermore,although the processes of FIGS. 7 and 8 are shown as separate steps, ifshould be understood that the garment may be arranged in a manner thatallows these heat sealing processes to occur substantially in parallel.

Finally, if the garment was turned inside out to facilitate assembly ofthe sensor arrangement, the garment may be everted again to restore thegarment to the intended wearable state.

EXAMPLES

FIGS. 9A, and 11-38 depict multiple variations of a system formonitoring a user, including a garment configured to be placed on thefoot of a user. The exemplary garments include a sensor arrangementextending from the ankle region of the garment to the sole region of thegarment, where each sensor lead in the arrangement is coupled to asensor on the sole region of the garment configured to measure thetemperature of the foot of a user. The sensor arrangement of the garmentdepicted in FIGS. 9A, and 11-38 includes a curved configuration alongthe heel region of the garment. The garments depicted in FIGS. 9A, and11-38 may be manufactured using any suitable methods, such as thosedescribed above. For example, the sensor arrangement may be coupled tothe garment by situating the sensor arrangement within a cover, and heatsealing the cover to the garment. The sensor arrangement may also beplaced in a protective film prior to be coupled to the garment, asdescribed above. The housing may be attached to the garment in anysuitable manner (e.g. by placing the housing in a cover and heat sealingthe cover to the garment, using an adhesion mechanism such as a snapfit, etc.). In FIG. 9A, the housing 940 is a box-like component with arectangular cross section located on the ankle region 914 of the garment910, however, the housing may include any suitable size, shape, andlocation. The proximal ends of sensor leads may be coupled to thehousing in any suitable manner (e.g. using an epoxy to couple the leadsand seal them to the housing).

In some variations, garments may comprise markings to indicate whichfoot of a user the garment is intended to be worn on. In othervariations, garments may not comprise a marking indicating what foot thegarment is intended to be worn on. For example, FIGS. 11-17 depictvarious views of a garment (with optional foot-designator marking)configured to be worn on a right foot, and FIGS. 18-24 depict variousviews of a garment (with optional foot-designator marking) configured tobe worn on a left foot. FIGS. 25-31 depict various views of a garmentconfigured to be worn on a right foot, where the garment includes afoot-designator marking (“R”) indicating that the garment is intended tobe worn on a right foot. FIGS. 32-38 depict various views of a garmentconfigured to be worn on a left foot, where the garment includes afoot-designator marking (“L”) indicating that the garment is intended tobe worn on a left foot. The foot-designator marking may be adhered tothe garment in any suitable manner. For example, a marking such as an“R” or an “L” (as depicted in FIGS. 28 and 36, for example) indicatingto a user what foot the garment is intended to be worn on may be knittedor embroidered into the garment, may comprise a patch sewn onto thegarment or otherwise adhered to the garment, a decal ironed or otherwiseadhered to the garment, may be made using fabric dye, etc.

The foregoing description, for purposes of explanation, used specificnomenclature to provide a thorough understanding of the invention.However, it will be apparent to one skilled in the art that specificdetails are not required in order to practice the invention. Thus, theforegoing descriptions of specific embodiments of the invention arepresented for purposes of illustration and description. They are notintended to be exhaustive or to limit the invention to the precise formsdisclosed; obviously, many modifications and variations are possible inview of the above teachings. The embodiments were chosen and describedin order to explain the principles of the invention and its practicalapplications, they thereby enable others skilled in the art to utilizethe invention and various embodiments with various modifications as aresuited to the particular use contemplated. It is intended that thefollowing claims and their equivalents define the scope of theinvention.

1-54. (canceled)
 55. A system for monitoring a user, the systemcomprising: a garment configured to be placed adjacent a body part ofthe user; a cover coupled to the garment; and a sensor arrangementbetween the garment and the cover, wherein the sensor arrangementcomprises at least one sensor to measure at least one parameterassociated with the body part of the user; and a housing between thegarment and the cover, wherein the cover is sealed to the garment arounda perimeter of the sensor arrangement and the housing.
 56. The system ofclaim 55, wherein the garment comprises a recessed portion for receivingat least a portion of the sensor arrangement.
 57. The system of claim55, wherein the at least one sensor is arranged on a sole region of thegarment at a location selected from an ossa digit region of the garment,between a phalange region and a metatarsal region of the garment,between the metatarsal region of the garment and a tarsal region of thegarment, and a heel region of the garment.
 58. The system of claim 55,wherein the cover is sealed to a sole region of the garment.
 59. Thesystem of claim 55, wherein the cover comprises a textile.
 60. Thesystem of claim 55, wherein the housing encloses a proximal portion ofthe sensor arrangement.
 61. The system of claim 55, wherein the housingcomprises at least one of a controller, a wireless communication module,a power supply, and a memory.
 62. The system of claim 61, wherein thehousing comprises a controller, wherein the controller operates in aninactive state in response to an indication that the garment is notbeing worn by the user, and operates in an active state in response toan indication that the garment is being worn by the user.
 63. The systemof claim 62, wherein in the active state, the controller is configuredto receive data from the at least one sensor.
 64. The system of claim55, wherein the sensor arrangement comprises a plurality of sensorleads, each sensor lead coupled to a respective sensor.
 65. The systemof claim 64, wherein the sensor leads are arranged in a flattened bundletraversing the garment.
 66. The system of claim 65, wherein the bundleis shaped to follow a curved path.
 67. The system of claim 66, whereinthe curved path comprises a serpentine portion.
 68. The system of claim67, wherein the serpentine portion is on a sole region of the garment.69. The system of claim 65, wherein at least one sensor lead comprises adistal portion, wherein the distal portion and the respective sensor ofthe at least one sensor lead diverge from the bundle.
 70. The system ofclaim 65, wherein at least a portion of the bundle is sealed withinpolymer film.
 71. The system of claim 55, wherein the at least onesensor comprises a temperature sensor.
 72. The system of claim 55,wherein the at least one sensor comprises a pressure sensor.
 73. Thesystem of claim 55, wherein the at least one sensor comprises at leastone selected from the group consisting of a moisture sensor, a strainsensor, a weight sensor, a muscle activity sensor, a motion sensor, andan orientation sensor.
 74. The system of claim 55, wherein the garmentis one selected from the group consisting of a sock, an insole, and ashoe.